Key considerations for hMSC product and process development through clinical cGMP manufacturing

Jan A. Nolta, Ph.D., is the Director of the Stem Cell Program at University of California Davis School of Medicine and directs the Institute for Regenerative Cures and the new UC Davis Gene Therapy Center. She also serves as the Scientific Director of the large UC Davis Good Manufacturing Practice Facility, and as PI of the California State Umbilical Cord Blood Collection Program. The UC Davis stem cell program has a large number of basic, translational, and clinical scientists collaborating to work toward regenerative medicine-related cures for a spectrum of diseases and injuries. Dr. Nolta is helping UC Davis teams develop numerous clinical trials of gene and cell therapy, with 40+ stem cell/regenerative medicine therapies already in the clinic, and over twenty in the pipeline. A California Institute for Regenerative Medicine “Alpha Clinic” Award was recently granted to UC Davis to administer FDA-approved stem cell and regenerative medicine therapies. A scientist with 30 years’ experience with human Hematopoietic and Mesenchymal stem cells, gene therapy, and clinical trial development, Dr. Nolta developed her passion for cellular therapy in the early 90’s by helping to develop and administer the first umbilical cord blood hematopoietic stem cell gene therapy trials for newborns with “bubble baby disease” with her mentor Donald Kohn at the University of Southern California. Dr. Nolta has published over 200 peer-reviewed manuscripts in the stem cell field, with over 13,000 citations, and has authored 30+ book chapters. She has served on over 250 review panels for the National Institutes of Health and other grant-funding agencies, was editor of the Book "Genetic Engineering of Mesenchymal Stem Cells", and has been Editor-in-Chief for the Journal “Stem Cells” for the past seven years.

Carolyn Yeago, Ph.D. is a Principle Scientist and Associate Director of Research at the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) at Georgia Institute of Technology, and also serves as a co-Industry Liaison Officer for the National Science Foundation Engineering Research Center for Cell Manufacturing (CMaT). She brings a unique background to these roles, with significant industry experience in medical and combination devices, including early stage technology development and assessment, business development, and strategic marketing to inform new product platform acquisitions. Dr. Yeago is responsible for overseeing research and development activities supported by the MC3M, leads a team of scientists to advance the clinical use and commercial production of therapeutic cells, and helps build and integrate industry consortium members to advise impactful research and development activities. Dr. Yeago returned to Georgia Tech after 7 years with Halyard Health and Kimberly Clark Health Care where she directed research and evaluated technologies to inform new platform strategies. She managed multiple projects and cross-functional teams spanning a variety of areas, including nanoparticle development and performance for long-lasting local anesthetic delivery, fundamental research on nerve damage and regeneration post radio-frequency ablation, and organic and inorganic growth strategies for digestive health and wound healing businesses. Dr. Yeago brings a passion for connecting related research and ensuring commercial relevance and translation. Dr. Carolyn Yeago received her Ph.D. in Biomedical Engineering from the Georgia Institute of Technology and Emory University, her B.S. in Biomedical and Bioengineering from North Carolina State University, and her graduate research focused on hydrodynamic modulation of embryonic stem cell differentiation.

James Birkhead is a Director in the Research & Development group at Vericel Corporation in Cambridge, MA. In this role, Mr. Birkhead is responsible for defining and implementing process changes in support of Vericel’s two commercial cell therapy products Epicel® (cultured epidermal autografts) skin grafts to treat life-threatening severe burns and MACI® (autologous cultured chondrocytes on porcine collagen membrane) to repair damaged knee cartilage. Mr. Birkhead has over 20 years’ experience with developing cell therapy products. Prior to Vericel, Mr. Birkhead was a senior scientist at Reprogenesis / Curis and Pervasis developing multiple cell therapy products from academia through clinical evaluations including managing technology transfer responsibilities with CROs. At Boston Scientific, he helped develop a novel tissue repair product for clinical and device integration indications. Mr. Birkhead studied cartilage biology while at Massachusetts General Hospital (Arthritis Research Unit) and at OsteoArthritis Sciences, a start-up company investigating novel inhibitors of cartilage degradation pathways. Mr. Birkhead received his Bachelor of Arts degree in biological science from the University of Delaware, Newark, DE.